EP0502905B1 - Gefässchirurgische vorrichtungen - Google Patents

Gefässchirurgische vorrichtungen Download PDF

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Publication number
EP0502905B1
EP0502905B1 EP90917487A EP90917487A EP0502905B1 EP 0502905 B1 EP0502905 B1 EP 0502905B1 EP 90917487 A EP90917487 A EP 90917487A EP 90917487 A EP90917487 A EP 90917487A EP 0502905 B1 EP0502905 B1 EP 0502905B1
Authority
EP
European Patent Office
Prior art keywords
wall
chamber
annular
portions
inflation
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP90917487A
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English (en)
French (fr)
Other versions
EP0502905A1 (de
Inventor
Taha Roudan Roudan Cottage Cadwell Estate Lazim
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BTG International Ltd
Original Assignee
British Technology Group Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by British Technology Group Ltd filed Critical British Technology Group Ltd
Publication of EP0502905A1 publication Critical patent/EP0502905A1/de
Application granted granted Critical
Publication of EP0502905B1 publication Critical patent/EP0502905B1/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A61F2002/077—Stent-grafts having means to fill the space between stent-graft and aneurysm wall, e.g. a sleeve
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas

Definitions

  • the invention is concerned with improvements in or relating to devices suitable for use in vascular surgery, particularly but not exclusively for use in substitution for or replacement of a damaged or malformed region of vessel or other conduit normally adapted to carry a fluid flow in mammals.
  • the invention in particular, relates to surgical devices as specified in the preamble of Claim 1. Such devices are known from US-A-4183102.
  • the invention provides a surgical device according to Claim 1.
  • the tubular wall arrangement of the body member comprises an inner flexible wall portion and an outer, substantially coaxial, wall portion, said wall portions being sealed to each other at end portions thereof to form an annular wall chamber, the means to render the flaccid wall arrangement into a relatively rigid condition comprising inflation means to inflate the annular wall chamber.
  • the outer wall portion of the annular wall chamber is common with and shared by the annular outer chamber, forming its inner surface.
  • the annular wall chamber is inflated to a pressure higher than that of the annular outer chamber, the pressure in said outer chamber being such that the sleeve member is readily conformable to the contours of the interior surface of the intervening passageway region.
  • the monitoring means may include a perforated probe projecting into, for example, the blood passing through an artery or vein. Such a probe may conveniently enter the device through a sealed aperture through which also pass inflation tubes leading to the inflatable chamber(s).
  • the tubular wall arrangement comprises an inflatable annular chamber, which is to be inflated to an extent at which it becomes, reasonably rigid, may be prevented from undue distortion or "ballooning" by the provision of ties spanning the annular chamber in a radial manner to link outer and inner wall portions.
  • the annular chamber comprises a plurality of interconnected longitudinally arranged inflatable channels, conveniently having intervening plain areas.
  • a device may be used to form a conduit or a closure for a fistula which may be of a naturally occurring type such as a vascular defect affecting babies where a pre-birth pulmonary by-pass passage fails to close or, alternatively, requires to be kept open for a certain time.
  • Other examples may be required for use as a result of injury such as a penetrative wound or pathological condition which forms a communication between the trachea and oesophagus or between an artery and a vein.
  • a device according to the invention While it is often convenient for a device according to the invention to be introduced through the femoral artery, it may be preferred to arrange to introduce the device through the sub-clavian artery.
  • Aortic aneurysms may occur at any region of the aorta, those above the diaphragm being referred to as thoracic aortic aneurysms and those below being known as abdominal aortic aneurysms, (A.A.A.).
  • a device according to the invention may be used to achieve this aim.
  • the first device comprises an inflatable tubular body 2 having open end portions 4, 6 to provide a passageway therethrough in the direction shown by arrows A.
  • the tubular body 2 comprises an inner wall portion 8 and an outer wall portion 10 which in the present example are of reinforced polyvinylchloride sheet material, each portion being sealed at said end portions to the other portion to form an annular wall chamber B. It will be understood that other bio-compatible materials may also be utilised.
  • a sleeve member 12 which in the present example is of polyurethane sheet material, and which together with an outer surface wall portion 10 defines an annular outer chamber, C, as shown in Figures 2 and 3.
  • the chambers are adapted to be inflated as will be explained below, the modification shown in Figure 3 including wall tie members 14 adapted to reduce any tendency for distortion of the chamber B by undue ballooning of the wall portions 8 and 10.
  • the two pipes are formed into an assembly with a hollow flexible probe 24 comprising a tube having a plurality of sampling apertures 26 at a leading end thereof which conveniently projects beyond the end portion 4 of the wall portions 8, 10 of chamber B so as to have access to the fluid flowing in the direction of arrow A, upstream of the device.
  • Sampling apparatus may be attached to the probe 24 at an outer end 28 thereof.
  • the probe arrangement may be used for monitoring blood pressure, taking samples, in angiography, or in association with other sensors.
  • chamber C Inflation of chamber C through the line 18 meanwhile causes the sleeve member 12 to conform to the shape of the aneurysm allowing for the presence of thrombus.
  • the tear 38 is sealed by the wall portion 12 and the aneurysm generally supported by the inflated chamber C.
  • chamber C is inflated to a pressure level, say, 2,67-6,67 kPa (20-50mm Hg), less than that required for the chamber B which may be 13,3-20 kPa (100-150mm Hg).
  • Figure 8 shows an alternative arrangement which is suitable for use in many circumstances and is particularly suitable where the device is introduced through the sub-clavian artery. It appears that the device illustrated has the advantage of minimising the further quantity of blood entering the aneurysm.
  • the device shown in Figure 8 comprises a chamber B'' of the construction shown in Figures 5 and 7 comprising passages 46 and having intervening solid wall portions 50.
  • Chamber C' is defined by the outer surface of chamber B'' and an outer wall 52 which is flexible but substantially inelastic. It is arranged that chamber B'' projects at each end, beyond the chamber C.
  • the shape of the wall 52 when inflated gives an area of widest diameter at 54 (approximately 55mm in one example) tapering downwardly to about 30mm at the area 56.
  • FIG. 8 This comprises a supply pipe 62 for inflating the passages 46 of chamber B'' and a supply pipe 64 for inflating the chamber C.
  • Each pipe 62, 64 is provided with a one-way valve 66,68, at a region adjacent a joining zone between the pipes 62 and 64 and extensions 70 and 72 which are connected at their remote ends to a source of CO2 gas.
  • a sampling probe 74 the leading end 76 of which projects beyond the leading edge 58 of the device, is also provided with an extension 78, the three extensions being joined by suitable means at 80. It will be understood that the extension 78 is provided at its remote end with a sampling connector to attach to a clinical syringe.
  • the device thus forms an internal by-pass for the aortic blood flow and may remain in place temporarily at least until the condition of the patient has stabilised so that conventional surgical techniques may be applied, for example the replacement of the damaged region of the vascular wall by a graft of suitable plastics material. If, however, the patient's condition is such that further surgery is inadvisable, then the device according to the invention may remain in place for a much longer period. Suitable materials will be chosen to permit such an option to be available, that is, materials which do not cause adverse reaction when in situ. Where the device is intended to be effectively permanent, the conduit holding the lines 16 and 18, together with the monitoring probe, may be disconnected at a suitable location.
  • a device which includes two inflatable chambers, one inflated to a pressure level such that a reasonably rigid tubular passageway is achieved and the other, surrounding the first, to assist in sealing and supporting damaged areas.

Claims (11)

  1. Chirurgische Vorrichtung, geeignet zum Einsatz in einen Strömungsmitteldurchgang im Körper, um einen geschädigten oder deformierten Teil des Durchgangs durch Ausbilden einer Verbindung zwischen zwei relativ fehlerfreien Teilen des Durchgangs, die durch den dazwischenliegenden geschädigten oder deformierten Bereich des Durchgangs voneinander beabstandet sind, zu überbrücken, wobei die Vorrichtung einen im wesentlichen rohr- oder schlauchförmigen Körperteil (2) umfaßt, der offene Endabschnitte (4,6) besitzt, und wobei das Körperteil eine rohr- oder schlauchförmige Wandanordnung (8) umfaßt, die unmittelbar vor dem Gebrauch in einem inoperativen, schlaffen Zustand ausgelegt ist, und wobei Mittel vorgesehen sind, um die schlaffe Wandanordnung in einen relativ steifen Zustand zu bringen, wenn die Vorrichtung in Gebrauchsstellung innerhalb des Strömungsmitteldurchganges ist, dadurch gekennzeichnet, daß die chirurgische Vorrichtung ferner folgendes umfaßt: ein äußeres Hülsenglied (12), dessen eines Ende am Körperteil, angrenzend an einem der offenen Endabschnitte und dessen anderes Ende am Körperteil angrenzend am zweiten offenen Endabschnitt befestigt ist, um eine ringförmige äußere Kammer (C) um den genannten Körperteil herum auszubilden, wobei das äußere Hülsenglied aus flexiblem Material geformt ist, um ein Aufblasen dieser ringförmigen äußeren Kammer zu ermöglichen, und daß ferner Mittel zum Aufblasen der ringförmigen äußeren Kammer vorgesehen sind, die dazu beitragen, daß die schlaffe Wandanordnung in einen relativ steifen Zustand gebracht wird.
  2. Vorrichtung nach Anspruch 1, bei der die rohr- oder schlauchförmige Wandanordnung des Körperteils einen inneren, flexiblen Wandabschnitt (8,42) und einen äußeren, im wesentlichen koaxialen Wandabschnitt (10,44) aufweist, wobei diese Wandabschnitte an deren Endteilen miteinander verbunden sind, unter Ausbildung einer ringförmigen Wandkammer (B), wobei Mittel vorgesehen sind, um die schlaffe Wandanordnung in einen relativ steifen Zustand zu bringen, die Aufblasmittel umfassen, um die ringförmige Wandkammer aufzublasen.
  3. Vorrichtung nach Anspruch 2, bei der der innere Wandabschnitt und der äußere Wandabschnitt miteinander in Abständen durch Stegteile (48) verbunden sind, die die Wandabschnitte überbrücken.
  4. Vorrichtung nach Anspruch 3, bei der die Stegteile so angeordnet sind, daß sie eine Reihe in Längsrichtung angeordneter, miteinander verbundener Durchgänge (46) vorsehen.
  5. Vorrichtung nach Anspruch 1, bei der die ringförmige Wandanordnung des Körperteils einen flexiblen Wandabschnitt umfaßt, welcher Durchgänge besitzt, die darin mit dazwischenliegenden festen Wandabschnitten (50) ausgebildet sind, und wobei Mittel zum Überführen des Körperteils in einen relativ steifen Zustand Aufblasmittel umfassen, um die Durchgänge in den flexiblen Wandabschnitten aufzublasen.
  6. Vorrichtung nach Anspruch 1, bei der der äußere Wandabschnitt (10,44) der ringförmigen Wandungskammer (B) Teil der ringförmigen äußeren Kammer (C), die ihre innere Fläche bildet, ist.
  7. Vorrichtung nach Anspruch 6, bei der das Material, aus dem die äußere Kammer (C) gebildet ist, leicht im Gebrauch an die Kontur der Innenfläche des dazwischenliegenden Strömungsmitteldurchgangsbereiches im Körper anpaßbar ist.
  8. Vorrichtung nach Anspruch 6, bei dem das Material, aus dem die äußere Kammer (C) gebildet ist, unelastisch ist.
  9. Vorrichtung nach Anspruch 8, bei dem die äußere Kammer in ihrem aufgeblasenen Zustand eine Doppel-Kegelkonfiguration annimmt, deren größter Durchmesser (54) am ringförmigen Bereich liegt, wenn die Grundflächen beider Kegelkonfigurationen miteinander verschmelzen.
  10. Vorrichtung nach einem der vorstehenden Ansprüche, bei der Überwachungsmittel vorgesehen sind, einschließlich einer perforierten Sonde (24), die sich über einen vorderen Endabschnitt (4) der Vorrichtung hinaus erstreckt und einschließlich einer rohrförmigen oder schlauchförmigen Leitung zu einer Probennahmevorrichtung.
  11. Vorrichtung nach Anspruch 10, bei dem die Sonde (24) eine Stütze für das Aufblasmittel darstellt.
EP90917487A 1989-12-01 1990-11-30 Gefässchirurgische vorrichtungen Expired - Lifetime EP0502905B1 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB8927282 1989-12-01
GB898927282A GB8927282D0 (en) 1989-12-01 1989-12-01 Vascular surgical devices
PCT/GB1990/001871 WO1991007927A1 (en) 1989-12-01 1990-11-30 Vascular surgical devices

Publications (2)

Publication Number Publication Date
EP0502905A1 EP0502905A1 (de) 1992-09-16
EP0502905B1 true EP0502905B1 (de) 1994-09-14

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP90917487A Expired - Lifetime EP0502905B1 (de) 1989-12-01 1990-11-30 Gefässchirurgische vorrichtungen

Country Status (7)

Country Link
US (1) US5330528A (de)
EP (1) EP0502905B1 (de)
JP (1) JPH05505115A (de)
AT (1) ATE111332T1 (de)
DE (1) DE69012584T2 (de)
GB (1) GB8927282D0 (de)
WO (1) WO1991007927A1 (de)

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ATE111332T1 (de) 1994-09-15
DE69012584T2 (de) 1995-01-12
JPH05505115A (ja) 1993-08-05
GB8927282D0 (en) 1990-01-31
US5330528A (en) 1994-07-19
DE69012584D1 (de) 1994-10-20
WO1991007927A1 (en) 1991-06-13
EP0502905A1 (de) 1992-09-16

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